Tag Archives: FDA

With tens of thousands of deaths attributed to prescription painkillers just in the past few years, it is little wonder why policy makers and healthcare professionals are seeking every avenue possible to help save more lives now in the face of this epidemic.

The Food and Drug Administration (FDA) recently held a meeting regarding the risk evaluation of extended-release and long-acting opioids. One of the topics of discussion was whether or not all physicians should be required to have specific training on narcotic pain medication to help prevent over-prescribing scenarios. The FDA panel concluded that they should receive such training in order to receive their prescriber number from the Drug Enforcement Administration (DEA).

Although the American Medical Association (AMA) has developed their own task force regarding preventing opioid abuse, they are generally opposed to the mandatory training, stating that some doctors don’t prescribe painkillers at all and therefore shouldn’t be subjected to it. However, the advisory committee for the FDA saw things differently.

There is an acknowledgment that over-prescribing of painkillers has been one component to the opioid crisis we face, but previous efforts to provide continuing education to physicians fell short of expectations. Therefore, the advisory committee approved the measure unanimously, and also made additional recommendations, such as mandatory education for patients receiving prescription narcotics.

In order to implement the mandates, legislative action will now have to be taken to follow through with the recommendations of the FDA panel. Hopefully the action can be quickly addressed within the House and the Senate. It is possible that the move may take the form of an amendment to the Comprehensive Addiction and Recovery Act (CARA).

Despite the FDA ruling that many diet supplements had to be recalled due to the fact that they contained pharmaceutical drugs, some of these supplements are still available to customers and oftentimes with the same or similar drugs still in them.

The rule is this; diet supplements are legal for consumption as long as they are made up of vitamins, herbs and other natural ingredients. Diet supplements go against FDA regulations if they contain any sort of pharmaceutical chemical. For instance, Mince Belle was a dietary supplement aimed at helping with weight loss. It was banned when the FDA found that one if it’s ingredients (not listed on the bottle) was sibutramine, which was a habit-forming drug that was pulled from the market.

People in our society have proven that addiction can come in many forms. Some people are heroin addicts, some are gambling addicts, some are sex addicts and some get addicted to diet pills. Diet pills can be especially addictive because they oftentimes mimic the effects of stronger stimulants. They give a person an artificial boost of energy and the person does not feel compelled to eat. Their day is spent working off the “high” the diet pills provided. Sometimes in order to get some sleep at the end of the day, the person will have to consume sleeping pills. This yo-yo way of living is not only unhealthy, but it is identical to that of a drug addict. While the FDA has worked to eliminate these types of supplements from the market it is clear that some manufacturers are still able to sell them to consumers.

A recent study conducted looked into 27 dietary supplements that had been recalled by the FDA. The reason for the recall was because all of these drugs had pharmaceutical ingredients within the supplement that was not listed on the ingredient list. Researchers wanted to see if manufacturers were still selling the supplements with pharmaceutical drugs as part of the recipe, either the same drugs that got them banned in the first place, or new pharmaceutical drugs. Of the 27 drugs tested 66.7 percent still contained pharmaceutical drugs.

It is clear that some supplement manufacturers are creating drugs being masked as supplements. These drugs can be dangerous, especially if not taken without the supervision of a physician. Taking drugs without a prescription enhances a person’s chances of becoming an addict and seeking out other street drugs to illicit the same high. It is always a good idea to become an educated consumer and research any supplement or drug you ingest, including any known side effects or potential for abuse.

“If appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy,” Hamburg stated.

Since the FDA approved Zohydro last fall, Hamburg has received letters protesting the decision from 28 state attorneys general and four senators, among others. Law enforcement agencies and addiction experts predict the approval of the drug will lead to an increase in overdose deaths, worsening the prescription drug abuse epidemic in the United States.

Zohydro is the first prescription narcotic to be composed of pure hydrocodone. Unlike other hydrocodone drugs, Zohydro does not contain acetaminophen, which can be toxic to the liver. Zohydro is also extremely potent compared to other hydrocodone drugs. That, along with its lack of tamper-resistant features, is the main cause for the uproar surrounding the drug and its manufacturer, Zogenix.

Zohydro is designed to be released over time, but it can be crushed and snorted by people seeking a strong, quick high. “I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction,” said Hamburg.

Zohydro was approved for use of patients who require daily, long-term treatment that cannot be treated with other drugs. Despite concerns over the potential for addiction, the drug is on track to be available this month.

Many are relieved that Purdue Pharma recently announced intentions to submit a tamper-resistant hydrocodone drug to the FDA later this year. Hopefully it won’t be too long until a safer alternative with abuse-deterrent features will be on the market.

Painkillers containing hydrocodone are typically the most commonly prescribed in the United States, and the Food and Drug Administration (FDA) recently recommended tightening the regulations surrounding prescriptions for the drug to be similar to those containing oxycodone.

According to a story in the New York Times, popular brand name drugs such as Vicodin and Lortab would be affected by a change in the regulations, which could take place as early as the first of the year. This wold require people to present themselves at a pharmacy, rather than having a doctor’s office call it in, and it would also limit the number of pills begin given.

Nationwide there has been a heavy focus on finding ways to combat prescription drug abuse, especially narcotic painkillers. Many states have changed laws regarding the sale and distribution of these powerfully addictive drugs. The problem rose to become an epidemic over the past decade or more, with overdose deaths from medications outnumbering those of street drugs.

This announcement comes during the same week where the FDA approved the sale and distribution of a new extended-releasd drug containing hydrocodone to treat long-term chronic pain.

It is vitally important for people to realize that just because it comes from a doctor in a pill bottle doesn’t necessarily mean it is going to be a safer drug to take. Prescriptions can be just as harmful as illicit substances, and even more so in some cases.

If you know someone who needs help for a problem with prescription painkillers, contact Desert Cove Recovery today.